Electrical acupoint stimulation for psychiatric sequelae in women victims of domestic violence: study protocol for an assessor-blind randomized controlled trial.

BACKGROUND

Domestic violence is a global public health problem linked to mental illness morbidity. A significant proportion of domestic violence victims have been found to exhibit unsatisfactory response rates to first-line treatments and display low acceptance levels towards psychological interventions. To improve the therapeutic effectiveness for this population, we aim to develop an electrical acupoint stimulation modality that integrates clinic-based and home-based therapies, with the goal of improving the psychiatric symptoms experienced by women victims of domestic violence.

METHODS

This is an assessor-blinded randomized controlled trial, consisting of 110 women victims diagnosed with depression. The patients will be randomly assigned to either the treatment group or the routine care group in a 1:1 ratio. The treatment group will receive electrical acupoint stimulation over a period of 12 consecutive weeks, in addition to their routine care. On the other hand, the routine care group will not receive any electrical acupoint stimulation until the end of the 12-week study. The primary outcome of the study is the mean change in the score of Beck Depression Inventory-II (BDI-II) from baseline to the end of the 12-week treatment. Secondary outcomes will include the 17-item Hamilton Depression Rating Scale (HAMD-17), 10-Item Perceived Stress Scale (PSS-10), PTSD Check List-Civilian Version (PCL-C), Insomnia Severity Index (ISI), 12-Item Short Form Survey (SF-12), as well as any observed adverse events.

DISCUSSION

If effective, this electrical acupoint stimulation modality could have significant clinical and research implications for women victims of domestic violence with psychiatric sequelae.

TRIALS REGISTRATION

ClinicalTrials.gov as NCT05102253. Registered 1 November 2021. https://www.

CLINICALTRIALS

gov/study/NCT05102253 .